Noninvasive Methods for Predicting the Occurrence of Decompensation in Chronic Liver Disease: a Prospective, Observational, Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 2,334
- 试验地点
- 1
- 主要终点
- Decompensation events
研究概览
简要总结
Preliminary studies have suggested that non-invasive methods can not only be applied to CSPH but also to predict the risk of decompensation in cirrhosis. However, there is a lack of clinical evidence, and more research is needed to provide such evidence. Especially in China, where the etiology of cirrhosis is prevalent, there is a large population of patients with hepatitis B cirrhosis undergoing antiviral treatment. Exploring the value of non-invasive methods in predicting decompensation events in these patients can not only expand the clinical application of non-invasive methods but also provide effective non-invasive screening and management strategies for patients with cirrhosis at different risk levels.
Primary Objective: The main purpose of this study is to evaluate the predictive effectiveness of non-invasive methods (based on liver and spleen stiffness) for the occurrence of decompensation in chronic liver disease (CLD).
Secondary Objectives: To establish different predictive models for the occurrence of decompensation in CLD and to assess their predictive effectiveness as non-invasive methods for decompensation in CLD.
Approximately 2334 individuals will participate in this study at 17 different health care Setting.The study will last for 4 years, including 1 year of enrollment and 3 years of follow-up. Patients will be seen at 6-month intervals, and all examination results of patients as well as decompensation events, liver cancer, and death will be recorded.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged over 18 years and under 80 years; ② Underlying chronic liver disease (etiology not specified);
- •Liver stiffness measurement (LSM) greater than 10 kPa or cirrhosis (diagnosed by imaging or histology);
- •Voluntarily signing an informed consent form.
排除标准
- •Have undergone orthotopic liver transplantation or Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure;
- •History of liver cancer or other types of cancer diagnosed in the past or currently;
- •Acute or chronic portal vein thrombosis; ④ History of splenectomy or splenic embolization; ⑤ Currently in a decompensated stage (with complications such as variceal bleeding, moderate to severe ascites, hepatic encephalopathy, etc.).
结局指标
主要结局
Decompensation events
时间窗: Patients were followed from the time of enrollment for a maximum of 3 years
Decompensated events included ascites, variceal bleeding, and hepatic encephalopathy
次要结局
未报告次要终点